# THE SPINAL CORD INJURY STANDARD OF CARE ACT
## A Proposed Federal Statute

*Draft for inclusion in the Apex Arc SCI Package*  
*Released under GPL-3.0 — open prior art*

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## FINDINGS

Congress finds the following:

**(1)** Approximately 18,000 new traumatic spinal cord injuries occur in the United States annually. The median age at injury is 43 years. Injuries peak in the 16-to-30 age range. The majority of people living with SCI will do so for decades.

**(2)** Traumatic spinal cord injury severs the communication pathway between the brain's motor commands and the muscles below the injury. It does not, in most cases, destroy the brain's capacity to generate commands or the muscles' capacity to respond to them. The injury is, in engineering terms, a wire problem.

**(3)** Since 2018, peer-reviewed publications in Nature Medicine and Nature Neuroscience have demonstrated that epidural electrical stimulation of the spinal cord can restore voluntary movement in patients with complete or clinically complete SCI. The question is no longer whether this is possible. It is.

**(4)** Since 2022, closed-loop stimulation systems have enabled SCI patients to walk unassisted over ground, navigate stairs, and perform functional upper-extremity tasks. These outcomes were obtained in patients with chronic, established injury previously considered permanent.

**(5)** The current standard of care for chronic SCI in the United States does not require, and in most cases does not include, any of these demonstrated interventions. Patients are referred to physical therapy, prescribed medications for pain and spasticity, and provided with a manual or power wheelchair. The gap between what is clinically possible and what is clinically provided is measured in decades of functional loss.

**(6)** The cost of a home robotics fleet sufficient to provide 24-hour independence for an SCI patient is estimated at $23,000 to $49,000. The cost of 24-hour human attendant care for the same patient is $60,000 to $150,000 per year. The current standard of care is not only less effective — it is more expensive.

**(7)** Federal restrictions on embryonic stem cell research from 2001 to 2009 delayed the development of stem cell therapies for SCI during a period of rapid scientific advancement. In the absence of federally funded alternatives, patients sought experimental adult stem cell-based interventions abroad, some of which carried risk profiles that resulted in documented neurological regression — regression that may not have occurred had domestically regulated alternatives been available.

**(8)** The Yamanaka method for generating induced pluripotent stem cells, published in 2006, made the ethical basis for the 2001 restriction obsolete. Federal stem cell funding restrictions remained in effect until 2009 — three years after the scientific basis for those restrictions had ceased to exist.

**(9)** People currently living with the consequences of that policy gap — additional neurological deficit caused by higher-risk procedures undertaken because federally funded lower-risk alternatives were unavailable — represent a specific and identifiable population whose care burden is a consequence of federal inaction.

**(10)** The technology to substantially improve function, independence, and quality of life for this population exists today, is commercially producible today, and is not being systematically provided today.

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## SHORT TITLE

This Act may be cited as the **"Spinal Cord Injury Standard of Care Act"** or the **"SCI Access Act."**

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## SECTION 1 — MINIMUM STANDARD OF CARE

**(a) MANDATORY NEUROLOGICAL ASSESSMENT**

Any healthcare provider receiving federal reimbursement who treats a patient with traumatic spinal cord injury shall, within 90 days of initial presentation or within 90 days of the enactment of this Act for patients currently under care, complete and document the following:

   (1) Full ASIA/ISNCSCI neurological classification examination  
   (2) Electromyography of all relevant muscle groups, bilateral  
   (3) Somatosensory evoked potentials at the injury level and below  
   (4) Motor evoked potentials via transcranial magnetic stimulation to bilateral limb targets  
   (5) Cervical or thoracolumbar MRI, as appropriate to injury level, documenting lesion characteristics and any surgically addressable compression

Failure to complete this assessment shall be documented in the patient record with clinical justification. "Patient has chronic injury" is not a clinical justification. "These assessments would not change the treatment plan" is not a clinical justification unless the treatment plan already includes every element required by this Act.

**(b) MANDATORY ASSISTIVE TECHNOLOGY EVALUATION**

Any healthcare provider treating a patient with motor-complete or motor-incomplete SCI at or above C8 shall, within 60 days of assessment completion, document an evaluation of the patient's eligibility for and access to:

   (1) Upper-extremity powered orthoses and mobile arm supports  
   (2) Eye-gaze or head-tracking augmentative communication and control systems  
   (3) Robotic feeding assistance devices  
   (4) Smart home voice and switch control integration  
   (5) Power wheelchair with updated control configuration appropriate to current functional status

The evaluation shall be updated any time there is a documented change in the patient's functional status, whether improvement or regression.

**(c) MANDATORY NEUROSTIMULATION REFERRAL**

Any patient with traumatic SCI who:

   (1) has chronic injury of twelve months or longer duration, AND  
   (2) has not achieved functional walking or functional upper extremity independence, AND  
   (3) has not had their candidacy for epidural, transcutaneous, or transcranial neurostimulation formally evaluated

shall be referred for such evaluation within 180 days of the enactment of this Act, or within 180 days of meeting the above criteria, whichever is later.

Referral shall be to a center with documented experience in spinal cord stimulation. Documentation of the referral, its outcome, and any barriers to completion shall be included in the medical record.

**(d) DOCUMENTATION REQUIREMENT**

For each element of subsections (a), (b), and (c) that is not completed, the medical record shall contain:

   (1) The specific element not completed  
   (2) The date by which it was due  
   (3) The clinical reason it was not completed  
   (4) The plan and timeline for completion

Absence of documentation shall constitute failure to meet the standard of care for purposes of federal reimbursement eligibility.

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## SECTION 2 — INSURANCE COVERAGE MANDATES

**(a) NEUROSTIMULATION DEVICES**

Any health insurance plan receiving federal subsidy, including but not limited to Medicare, Medicaid, and plans sold on Affordable Care Act exchanges, shall provide coverage for:

   (1) Epidural spinal cord stimulation implantation and ongoing management for patients with traumatic SCI  
   (2) Transcutaneous spinal cord stimulation systems for patients with traumatic SCI who are not surgical candidates or decline surgery  
   (3) Non-invasive brain stimulation systems, including transcranial magnetic stimulation and focused ultrasound neuromodulation, when prescribed for SCI motor rehabilitation

Coverage shall not be conditioned on the patient having failed any particular number of prior treatments unless those treatments are themselves covered and were actually offered.

**(b) ASSISTIVE ROBOTICS**

Any federal health insurance program shall cover the following, subject to functional eligibility criteria to be developed by the Secretary within one year of enactment:

   (1) Robotic feeding assistance devices for patients who cannot self-feed due to SCI  
   (2) Mobile manipulation systems for patients with complete cervical SCI when such systems provide documented independence gain  
   (3) Transfer assist devices when the patient's care plan requires human-assisted transfer more than twice daily

Coverage for robotic systems shall be evaluated against the cost of equivalent human attendant care hours for the same functional need. Where the ten-year total cost of a robotic system is less than the ten-year cost of human attendant care for the same need, coverage shall be presumed appropriate absent specific clinical contraindication.

**(c) FUNCTIONAL ELECTRICAL STIMULATION**

Coverage shall be provided for:

   (1) FES cycling systems for patients with lower extremity SCI  
   (2) FES upper extremity systems for patients with cervical SCI and residual proximal arm movement  
   (3) Wearable continuous neuromuscular stimulation garments when prescribed for maintenance of muscle mass and neuromuscular junction viability

**(d) APPEALS PROCESS**

Any denial of coverage for a device or intervention covered under this Section shall:

   (1) Be reviewed by a clinician with documented expertise in spinal cord injury  
   (2) Include specific citation to the clinical evidence supporting denial  
   (3) Be decided within 72 hours for urgent requests and 30 days for standard requests  
   (4) Be subject to expedited external review upon patient request

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## SECTION 3 — FEDERAL RESEARCH MANDATE

**(a)** The Director of the National Institutes of Health shall designate spinal cord injury as a priority area for translational research, with specific emphasis on:

   (1) Closing the gap between research center demonstration and home deployment for neurostimulation systems  
   (2) Long-term biocompatibility and efficacy of neural interface materials including graphene-based electrode arrays  
   (3) Rehabilitation outcomes in patients with chronic injury (ten years or more post-injury) to address the longstanding clinical assumption that chronic injury patients are not candidates for functional recovery

**(b)** The Secretary of Health and Human Services shall, within two years of enactment, publish and update annually a public registry of:

   (1) All neurostimulation systems with FDA clearance or approval for use in SCI  
   (2) All active clinical trials enrolling SCI patients  
   (3) All centers of excellence for SCI rehabilitation meeting criteria established by the Secretary

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## SECTION 4 — RECOGNITION OF POLICY-RELATED HARM

**(a) FINDING**

Congress recognizes that the executive restriction on federally funded embryonic stem cell research from 2001 to 2009 resulted in a period during which experimental stem cell interventions for SCI were available only through foreign providers operating outside the regulatory framework that would have applied to federally funded research. Some patients who underwent such interventions experienced adverse neurological outcomes including functional regression. The population of SCI patients who were in the prime intervention window during this period — roughly 2001 to 2009 — and who sought treatment abroad in the absence of federally funded alternatives constitutes a specific, identifiable group.

**(b) REMEDY**

The Secretary shall establish a program to:

   (1) Identify patients who underwent experimental SCI procedures abroad during the period 2001-2009 while federally funded alternatives were restricted  
   (2) Provide comprehensive neurological evaluation to those patients at no cost  
   (3) Ensure those patients receive priority access to all programs established under this Act  
   (4) Document the functional outcomes of that population for inclusion in the research registry established under Section 3

This is not an assignment of fault. It is a recognition that policy has consequences, that those consequences fall on specific people, and that it is within the power of the federal government to make that right.

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## SECTION 5 — ENFORCEMENT

**(a)** Any provider receiving federal reimbursement who fails to meet the documentation requirements of Section 1 shall be subject to:

   (1) First violation: written notice and mandatory corrective action plan  
   (2) Second violation within 24 months: suspension of federal reimbursement for SCI-related services pending remediation  
   (3) Third violation within 36 months: permanent exclusion from federal reimbursement for SCI-related services

**(b)** Any insurance plan that denies coverage required under Section 2 without meeting the appeals requirements of Section 2(d) shall be subject to civil penalty of not less than $10,000 per violation, with each denial constituting a separate violation.

**(c)** Nothing in this Act shall be construed to limit a patient's right to pursue civil claims under applicable state or federal law.

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## SECTION 6 — DEFINITIONS

**"Chronic SCI"** means traumatic spinal cord injury of twelve months or more duration.

**"Functional independence"** means the ability to perform activities of daily living — including feeding, hygiene, mobility, and communication — without requiring human physical assistance.

**"Neurostimulation"** means the application of electrical, magnetic, or acoustic energy to the nervous system for the purpose of modulating neural activity, including but not limited to epidural spinal cord stimulation, transcutaneous spinal cord stimulation, transcranial magnetic stimulation, and focused ultrasound neuromodulation.

**"Standard of care"** means the diagnostic and therapeutic interventions that a reasonably competent clinician with training in spinal cord injury medicine would provide to a patient with a given clinical profile, based on the best available evidence.

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## SECTION 7 — AUTHORIZATION OF APPROPRIATIONS

There are authorized to be appropriated such sums as may be necessary to carry out this Act.

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*Part of the Apex Arc SCI Package.*  
*Released under GPL-3.0. Copy it. Use it. Pass it.*